Preliminary exploration of safety and efficiency of external traction fixation in early-stage treatment of severe lower leg injuries--A retrospective cohort study

Preliminary exploration of safety and efficiency of external traction fixation in early-stage treatment of severe lower leg injuries--A retrospective cohort study | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Preliminary exploration of safety and efficiency of external traction fixation in early-stage treatment of severe lower leg injuries--A retrospective cohort study Junsheng Yang, Zhiwei Yang, Lei Zhao, Zixu Wang, Qing Xue, Zhongyang Sun, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6934471/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background: Staged treatment is commonly used for severe limb injuries, and optimizing early stabilization is crucial for successful definitive surgery. Calcaneal traction and external skeletal fixation are widely applied; however, both have limitations— discomfort of bedrest and traction line swing, or infection risk and surgical planning difficulty. Meanwhile, external traction fixation, a hybrid technique structurally similar to external fixation but biomechanically akin to skeletal traction, offers both mechanical stability and procedural convenience. This study aims to evaluate the safety and efficacy of external traction fixation as an early-stage treatment for severe lower leg injuries. Methods: We retrospectively analysed data from 92 patients with severe lower leg injuries treated at our hospital between May 2016 and May 2022. Patients (72 males, 20 females; mean age 46.6 ± 13.3 years) were divided into three groups based on the initial temporary fixation method: external traction fixation (Group A), calcaneal traction (Group B), and external skeletal fixation (Group C). Outcomes included peak creatine kinase and lactate levels within 48 hours post-injury, peak Visual Analog Scale (VAS) scores within 24 hours post-fixation, duration of the temporary fixation procedure, time to definitive surgery, and duration of definitive internal fixation. Limb function was evaluated at final follow-up using the Johner-Wruhs criteria. Results: Peak lactate levels were significantly lower in the external traction fixation group (Group A) compared to the other groups. The mean duration of definitive surgery was 69 ± 17 minutes (Group A), 89 ± 15 minutes (Group B), and 88 ± 15 minutes (Group C). After adjusting for confounders, definitive surgery was significantly shorter in Group A compared to Group B (mean difference: 20.60 minutes; 95% CI: 12.76–28.45; p < 0.001) and Group C (mean difference: 19.59 minutes; 95% CI: 11.62–27.50; p < 0.001). Postoperative infection rates were 7% (Group A), 3% (Group B), and 23% (Group C), with no significant difference after adjustment. The final excellent-good outcome rates (Johner-Wruhs criteria) were 93% (Group A), 78% (Group B), and 73% (Group C), with a significant difference between Group A and Group C. Conclusion: In the early-stage treatment of severe lower leg injuries, using external traction fixation to stabilize the injured limb is a safe and efficient technical choice. It is well compatible with subsequent definitive surgery and better facilitates the staged treatment strategy for severe limb injuries. Early-stage treatment External traction fixation Calcaneal traction External skeletal fixation Retrospective cohort study Severe limb injuries Figures Figure 1 Figure 2 Figure 3 Figure 4 Background Severe limb injuries (SLI) refer to limb damage caused by high-energy trauma, which can result in comminated fractures as well as severe muscle and skin contusions. The lower leg, in particular, has a unique anatomical structure, and following a severe limb injury, the early-stage condition and prognosis are highly uncertain. Complications such as compartment syndrome, bone and soft tissue infections, and a high disability rate may occur [1-3]. Blachut [4] and Horst [5] have suggested that active staged surgery is an effective treatment strategy. In the early phase of trauma, damage control surgical techniques can be used to achieve temporary stabilization of the injured limb, providing a time window for monitoring changes in the limb’s condition. Additionally, better preoperative preparation can improve the quality of definitive surgery, leading to better functional outcomes for the limb. In the overall staged treatment of limb injuries, the safety and efficacy of early-stage treatment techniques play a crucial role in determining the final therapeutic outcome [6, 7]. Among the early temporary fixation methods for limbs, external skeletal fixation is the most commonly used technique. Traditional external skeletal fixation emphasizes to purchase each bone fragments by using pins connected with rods to achieve fracture stability. However, placing fixation pins within the fracture area may further aggravates soft tissue damage in the injured region, and bacteria can invade the bone and soft tissues through the pin track, leading to secondary infections. According to Ziran et al. [8], excessive movement of muscles and skin around the fracture can trigger local inflammation, ultimately causing pin track infections. Bone tissue may undergo irreversible changes, including osteocyte necrosis and alkaline phosphatase inactivation [9]. Additionally, because external skeletal fixation involves placing pins near the fracture site, there is a higher risk of pin track infections, which can compromise definitive internal fixation surgery [10, 11]. Calcaneal traction is a traditional method of temporary fracture fixation that generally involves inserting a traction pin into the epiphyseal cancellous bone. This technique is simple and avoids placing fixation pins in the injury zone, reducing the risk of pin track infections compared to external skeletal fixation [12]. However, its disadvantages include instability in the traction force direction, which may cause secondary displacement of the fracture and further soft tissue damage [13]. Prolonged calcaneal traction can also lead to irregular changes in soft tissue tension around the fracture site due to patient repositioning, resulting in poor fixation effectiveness. Furthermore, because calcaneal traction requires connection to a traction frame, both the patient and the injured limb are immobilized, causing discomfort and reducing fracture stability during the fixation period [14]. External traction fixation is another commonly used limb stabilization technique. Schade et al. [15] applied this type of external fixation to the early reduction and fixation of tibia and fibula fractures, suggesting that it can be combined with plaster fixation as a treatment strategy in resource-limited settings. Yingze Zhang et al. [16] proposed the concept of the “rapid reduction device” utilizing a “bidirectional traction” mechanism. This device enables early fracture reduction and can also be used during definitive surgery to maintain reduction and assist in internal fixation procedures. By applying axial traction along the limb’s mechanical axis, this technique provides early relative stability to the limb. In our study, we modified the pin placement and structure of external fixation devices based on the principles of external skeletal fixation, incorporating the concept of traction to achieve temporary fracture fixation. We define this technique as external traction fixation, which expands the “bidirectional traction” concept to the early-stage treatment of severe limb injuries. By using external fixation with traction, fractures can be reduced and the injured limb temporarily stabilized in the early trauma stage, allowing for definitive surgery when conditions are appropriate. This method enables patient mobility during traction, while also addressing the invasiveness issues associated with external skeletal fixation pins. Although external traction fixation is commonly used for early fracture reduction and has seen some clinical application, there has been no systematic study evaluating its long-term effectiveness and safety in early-stage temporary fixation for severe limb injuries. In this study, we conducted a retrospective cohort analysis to investigate and compare the safety and efficacy of external traction fixation, calcaneal traction, and external skeletal fixation, in stabilizing the injured limb during the early stage of trauma. Clinical Data and Methods 1.1 Study Population This study retrospectively analysed 236 cases of severe lower leg injuries treated at the Air Force Hospital of the Eastern Theatre Command from May 2016 to May 2022.According to the following inclusion and exclusion criteria, a total of 92 patients were enrolled in the cohort study on early-stage treatment of severe lower leg injuries. The inclusion and exclusion flowchart are shown in Figure 1. The inclusion criteria required patients to be 18 years or older and diagnosed with severe lower leg injuries, including tibial (fibular) comminated fractures accompanied by skin and soft tissue envelop or complicated by compartment syndrome [17, 18]. Additionally, patients with open fractures of the tibia and fibula, where the fracture line extended to the knee or ankle joint surfaces, were eligible if they were scheduled for planned staged treatment [5]. The study focused on three early-stage temporary fixation methods: external traction fixation, calcaneal traction, and external skeletal fixation. To be included, patients were also required to have a follow-up period of at least 12 months after undergoing definitive internal fixation surgery. Patients were excluded if they were unable to cooperate with treatment due to mental illness or related symptoms. Additionally, cases with missing key study data were omitted from the final analysis. The study cohort included 92 patients, whose baseline characteristics are detailed in Table 1. Among the three treatment groups, the proportion of male patients was 83% in the external traction fixation group, 69% in the calcaneal traction group, and 83% in the external skeletal fixation group. The mean age (± standard deviation) for each group was 47 ± 15 years in the external traction fixation group, 47 ± 11 years in the calcaneal traction group, and 46 ± 13 years in the external skeletal fixation group. The causes of injury varied among patients, with traffic accidents accounting for 54 cases, while falls contributed to 38 cases. Regarding fracture locations, the study population included 26 cases of tibial plateau fractures, 38 cases of tibial shaft fractures, and 28 cases of distal tibial fractures. The proportion of open fractures was relatively high across all groups. Specifically, 70% of patients in the external traction fixation group, 78% in the calcaneal traction group, and 80% in the external skeletal fixation group had open fractures. The selection of early-stage treatment methods, including external traction fixation, calcaneal traction, and external skeletal fixation, was determined by a consistent team of treating physicians to minimize variability in clinical decision-making. The distribution of patients within each treatment category was 30 cases in the external traction fixation group (Group A), 32 cases in the calcaneal traction group using a calcaneal pin (Group B), and 30 cases in the external skeletal fixation group (Group C). Patients admitted to our hospital with severe lower leg injuries between May 2016 and May 2021 were retrospectively enrolled. Inclusion criteria were: (1) fresh, closed or Gustilo type I/II open fractures of the tibia and/or fibula; (2) age between 18 and 75 years; and (3) receipt of temporary fracture stabilization using one of three methods — external traction fixation, calcaneal traction, or external skeletal fixation — within 48 hours of injury. Patients were excluded if key clinical indicators were missing, or follow-up was incomplete. Specifically, 3 patients were transferred to local hospitals due to financial or insurance limitations, 2 patients died within one year of injury, 4 were transferred to internal medicine specialties due to acute comorbidities, and 6 were lost to follow-up despite multiple contact attempts. Additionally, 3 patients with post-traumatic neuropsychiatric disorders were unable to cooperate with treatment. These exclusions were determined to be random and unrelated to clinical outcomes, suggesting minimal risk of selection bias. 1.2 Limb Fixation Methods A group: External traction fixation Group The external traction fixation group utilized an external fixation device to achieve temporary limb stabilization through a traction-based mechanism. This method involved a systematic approach to positioning, disinfection, pin placement, and fixation to ensure effective fracture stabilization while minimizing soft tissue damage. The procedure began with patient positioning, where the injured individual was placed in a supine position with the affected limb elevated. This positioning facilitated both surgical access and traction application. Following positioning, disinfection was performed using hydrogen peroxide and diluted povidone-iodine, ensuring a sterile environment. A pulsed irrigation system was employed to thoroughly cleanse the wound, reducing contamination risk. Subsequently, routine surgical field preparation was conducted, including standard surgical disinfection and the application of a sterile drape. Pin placement played a crucial role in the success of external traction fixation. The most common skeletal traction sites selected for pin insertion included the calcaneal tuberosity and tibial tuberosity. The specific insertion points varied based on anatomical landmarks. For the calcaneal region, a 5 mm pin was inserted from the medial to lateral direction, with the entry point positioned at the midpoint of the line between the medial malleolus and the calcaneal tuberosity. The pin was then drilled outward through the lateral side. Meanwhile, for the tibial tuberosity region, a 5 mm pin was inserted in a lateral-to-medial direction, or tow 5 mm pins were individually placed laterally and medially, with the entry point located 3 cm lateral to the tibial tuberosity midline. The length of the medial and lateral pin ends outside of the skin was carefully adjusted to remain approximately equal, ensuring proper stability. Once the pins were in place, the fixation process commenced. Two assistants held the tibial tuberosity pin and calcaneal pin, carefully correcting rotational deformities while applying counter-traction along the tibial mechanical axis. To ensure rigid and effective stabilization, pin-rod clamps were used to connect two carbon fibber rods to the external fixation pins, thereby maintaining traction. If any open wounds were present, additional debridement and wound closure were performed to prevent infection and facilitate proper healing. Following the procedure, the pulsation of the dorsalis pedis artery was assessed to confirm adequate vascular perfusion, either by manual palpation or through Doppler ultrasound examination. The external traction fixation device was designed with several structural features to enhance its effectiveness. Firstly, pin placement was prioritized in the epiphyseal region to minimize soft tissue damage. Secondly, the technique utilized the soft tissue splinting principle, leveraging traction tension to achieve limb stabilization. Lastly, the pin placement strategy ensured that pins were inserted away from the injury zone and definitive surgery site, thereby protecting soft tissues and reducing the risk of iatrogenic injury. (Refer to Figure 2 for schematic diagrams of external traction fixation, calcaneal traction, and external skeletal fixation. Additionally, Figures 3 and 4 provide illustrative case examples.) B group: Calcaneal traction Group The calcaneal traction group employed calcaneal traction as the primary method of temporary immobilization (Figure 2). To begin the procedure, local anaesthesia was administered to minimize patient discomfort. Following anaesthesia, the surgical site was sterilized, and sterile draping was applied. If open wounds were present, wound debridement and suturing were performed to mitigate infection risks. Pin placement for calcaneal traction involved precise entry point selection. The entry site was identified as the midpoint of the line connecting the medial malleolus and the calcaneal tuberosity. A Schanz pin was then inserted in a horizontal direction, penetrating the calcaneus from medial to lateral. Once the traction pin was securely positioned, a traction bow was installed onto the Schanz pin. The traction bow was then connected to a pulley system at the foot of the bed via traction cords, applying a traction force of 4–6 kg. This setup allowed for gradual and controlled limb stabilization, facilitating soft tissue recovery and fracture management. C group: External skeletal fixation Group The external skeletal fixation group underwent temporary fracture stabilization through a standard pin-rod external fixation technique (Figure 2). The procedure began with patient positioning, where the individual was placed in a supine position. To ensure a sterile operative field, the injury site was thoroughly disinfected and irrigated according to standard surgical protocols. The pin placement strategy was crucial in ensuring fracture stability. Two sets of fixation pins were inserted into the proximal and distal main fracture fragments, with at least two pins per set to optimize mechanical support. Specifically, the near fracture-line pins were positioned 3–5 cm away from the fracture line, while the far fracture-line pins were placed as far apart as possible from the near pins to maximize stability. Following pin insertion, the final fixation process was performed. Short rods and clamps were used to connect the proximal and distal set of pins, ensuring that the fracture was properly aligned. Once alignment was confirmed, the fixation system was securely locked in place, providing immediate structural support for the injured limb. This method of external skeletal fixation was particularly effective in achieving temporary fracture stability while allowing for subsequent definitive surgical interventions. 1.3 Functional Evaluation To comprehensively assess the outcomes of early-stage temporary fixation methods, a range of clinical indicators were recorded and analysed. These evaluations focused on both short-term physiological responses and long-term functional recovery, ensuring a thorough understanding of the effectiveness of external traction fixation, calcaneal traction, and external skeletal fixation in the treatment of severe lower leg injuries. One of the primary parameters assessed was muscle damage, which was quantified by measuring peak creatine kinase (CK) and lactate levels within 48 hours of hospital admission. Creatine kinase serves as a biochemical marker of muscle injury, while lactate levels indicate tissue perfusion and metabolic stress, both of which are crucial in evaluating the degree of trauma sustained by the affected limb. Pain levels were also meticulously recorded to gauge patient discomfort and procedural effectiveness. The Visual Analog Scale (VAS) pain score, a widely used pain assessment tool, was employed to determine the peak pain levels within 48 hours after temporary fixation. Higher VAS scores were indicative of greater patient distress, providing insight into the relative comfort offered by each fixation method. Beyond these physiological markers, key hospitalization-related factors were documented. These included pre-hospital delay (time from injury to hospital admission), the duration of the temporary fixation procedure, the interval between temporary fixation and definitive surgery, and the total duration of definitive internal fixation surgery. These factors were essential in evaluating the efficiency of each fixation technique, as shorter fixation and surgery times often correlate with better patient outcomes and reduced surgical burden. Long-term functional recovery was evaluated through scheduled follow-ups, beginning two weeks after definitive surgery. Subsequent evaluations were conducted at six weeks, three months, and every six weeks thereafter until fracture healing was confirmed. At the final follow-up, patient outcomes were systematically assessed using the Johner-Wruhs scoring system, a widely recognized standard for evaluating lower limb functional recovery. The Johner-Wruhs criteria for evaluating outcomes of tibial shaft fractures categorize results into four grades—excellent, good, fair, and poor—based on the assessment of fracture healing, neurovascular injury, deformity, joint mobility, pain, gait, and the ability to perform daily activities [19]. Sex and age were obtained from ID information at admission. Injury side and cause were documented in the present illness history. Fracture site, AO classification, and open fracture grade were determined by a team of physicians based on radiographic interpretation. Pre-hospital time, defined as the interval from injury to emergency department arrival, was extracted from ambulance transfer records. Temporary fixation time and definitive surgery duration were obtained from surgical records. Laboratory values such as lactate and CK were measured using standard equipment (CK: Hitachi 7600-020 automatic biochemical analyzer; lactate: Radiometer ABL90 FLEX blood gas analyzer). VAS scores were recorded in nursing notes. 1.4 Statistical Analysis Statistical analyses were conducted using R software (version 4.3.2) to ensure rigorous and accurate evaluation of the study’s findings. The statistical approach varied based on the nature of the data, with different methods applied for continuous and categorical variables. For continuous variables that followed a normal distribution, data were expressed as Mean ± SD (Standard Deviation), and comparisons between groups were performed using analysis of variance (ANOVA). However, for continuous variables that did not conform to a normal distribution, results were presented as Median (Interquartile Range, IQR), and Kruskal-Wallis tests were used for group comparisons. For categorical variables, data were reported as frequencies (%), and group comparisons were conducted using the chi-square (χ²) test or Fisher’s exact test, depending on the expected sample size distribution. To control for potential confounding variables, regression analyses were performed to assess the impact of different temporary fixation methods on clinical outcomes. For continuous clinical outcomes, such as the duration of definitive surgery, linear regression was applied. In contrast, for binary clinical outcomes, including infection rates, secondary surgery rates, and the proportion of patients achieving excellent-to-good outcomes on the Johner-Wruhs scoring system, logistic regression was used. To ensure the validity and reliability of the regression models, diagnostic checks were conducted to verify that the assumptions of linearity, normality of residuals, independence, and absence of multicollinearity were met. The multivariate model selection process was based on three distinct strategies. The first strategy involved an initial univariate screening, where variables with P-values <0.1 were included in the multivariate model, followed by stepwise regression. The second strategy entailed the inclusion of all variables into a full model. The third strategy involved stepwise selection of variables from the full model, utilizing an Akaike Information Criterion (AIC)-based backward stepwise regression approach. Among the three models, the model with the lowest AIC value was selected as the optimal model for analysis. This model was subsequently used to estimate the between-group differences among the three temporary fixation methods, including the odds ratio (OR), 95% confidence interval (CI), and P-values. All statistical tests were conducted as two-sided tests, with a P-value of <0.05 considered statistically significant. This threshold ensured a rigorous evaluation of differences in clinical outcomes among the treatment groups, reinforcing the statistical credibility of the findings. 1.5 Ethical Considerations This study was approved by the Institutional Ethics Committee (Approval Number: 20150513-018) . Results 2.1 General Description of Early-stage treatment for Severe Lower Leg Injuries (Baseline Analysis) The duration of temporary fixation surgery for the three treatment groups varied significantly. The external traction fixation group required an average of 15 ± 5 minutes, while the calcaneal traction group had the shortest procedure time at 8 ± 2 minutes. In contrast, the external skeletal fixation group had the longest procedure time, averaging 31 ± 6 minutes. In terms of peak creatine kinase (CK) levels, which indicate the degree of muscle damage, the three groups showed distinct differences. The external traction fixation group recorded a median CK level of 520 (264, 957) U/L, while the calcaneal traction group had a lower median of 366 (164, 720) U/L. Conversely, the external skeletal fixation group exhibited the highest median CK levels at 883 (550, 1246) U/L, suggesting a greater degree of muscle injury in this group. The peak lactate levels, a marker of tissue perfusion and metabolic stress, also varied across groups. The external traction fixation group demonstrated the lowest mean lactate level at 2.09 ± 0.60 mmol/L, while the calcaneal traction group exhibited a higher mean of 2.57 ± 0.79 mmol/L. The external skeletal fixation group had an intermediate mean lactate level of 2.38 ± 0.56 mmol/L. Postoperative pain levels, assessed using the Visual Analog Scale (VAS) score, indicated notable differences among the groups. The external traction fixation group had a median VAS score of 2.00 (1.00, 3.00), while the calcaneal traction group reported a higher median pain score of 4.00 (3.00, 4.00), suggesting greater patient discomfort. The external skeletal fixation group had an intermediate median VAS score of 2.50 (2.00, 4.00). The time interval between temporary fixation and definitive surgery also varied among groups. The external traction fixation group had a mean interval of 8.1 ± 2.6 days, while the calcaneal traction group had a slightly shorter interval of 7.6 ± 2.5 days. In contrast, the external skeletal fixation group had the longest delay before definitive surgery, averaging 10.6 ± 4.8 days. A preliminary comparison between groups revealed statistically significant differences in temporary fixation surgery duration, interval to definitive surgery, VAS scores, and peak lactate levels. These findings suggest that different fixation methods have distinct impacts on operative efficiency, metabolic stress, pain levels, and recovery timelines. Further detailed statistical analyses of baseline characteristics are presented in Table 1. 2.2 Evaluation of Efficiency and Safety To assess the efficiency of different early-stage fixation methods, definitive surgery duration was selected as the primary outcome variable. A linear regression analysis was conducted, incorporating temporary fixation methods as well as other potential confounding variables, including sex, age, laterality of injury, cause of injury, fracture location, AO fracture classification, pre-hospital delay, and presence of open fractures as independent variables. The results are presented in Table 2. In the univariate analysis, only the temporary fixation method showed statistical significance (P < 0.1). Variables identified as significant in the univariate analysis were further analyzed using stepwise regression, which resulted in a model (stepwise model 1) that included only the temporary fixation method. A full model was also constructed, incorporating all potential influencing factors identical to those in the univariate analysis. A stepwise selection process was then applied to the full model, yielding stepwise model 2, which included temporary fixation method and age as the final predictors. The results showed that the temporary fixation method was statistically significant (P < 0.001). Across different models, the findings consistently indicated that temporary fixation method had a significant impact on definitive surgery duration. To determine the most optimal model, we compared the Akaike Information Criterion (AIC) values for stepwise model 1, the full model, and stepwise model 2. The model with the smallest AIC value was selected as the optimal model, and this model was subsequently used for effect estimation. To evaluate infection rates following definitive surgery, a logistic regression analysis was conducted. The independent variables included temporary fixation method, sex, age, laterality of injury, cause of injury, fracture location, AO fracture classification, pre-hospital delay, presence of open fractures, VAS pain score, and pre-hospital delay. In the univariate analysis, temporary fixation method, AO fracture classification, and age were statistically significant (P < 0.1, see Table 3). After performing stepwise regression, the age variable was eliminated, resulting in stepwise model 1. A full model was then built, incorporating all potential influencing factors. A stepwise selection process was applied to this model, producing stepwise model 2, which included temporary fixation method, cause of injury, AO fracture classification, and age. Through AIC comparison, stepwise model 2, which had the lowest AIC value, was selected as the optimal model. The odds ratio (OR) for temporary fixation method in this model indicated that the calcaneal traction group versus the external traction fixation group had an OR of 0.48 (95% CI: 0.02, 6.44), P = 0.6, while the external skeletal fixation group versus the external traction fixation group had an OR of 5.59 (95% CI: 0.85, 60.90), P = 0.1. Regarding AO fracture classification, the OR for type B fractures versus type A fractures was 0 (P > 0.9), while for type C fractures versus type A fractures, the OR was 0.69 (95% CI: 0.13, 3.65), P = 0.7. To assess unplanned secondary surgery rates, logistic regression analysis was again performed, using the same set of independent variables. In the univariate analysis, temporary fixation method was not significant (P > 0.1), but AO fracture classification and age showed statistical significance (P < 0.1, see Table 4). After stepwise regression, age was removed from the model, resulting in stepwise model 1. A full model was built using the same independent variables as the univariate analysis, and stepwise selection was applied, yielding stepwise model 2, which included temporary fixation method, AO fracture classification, and VAS pain score. Based on AIC comparisons, the model with the lowest AIC value was selected as the optimal model. In this model, the odds ratio (OR) for the calcaneal traction group versus the external traction fixation group was 7.27 (95% CI: 0.37, 300), P = 0.2, while the OR for the external skeletal fixation group versus the external traction fixation group was 11.8 (95% CI: 1.23, 310), P = 0.063. For AO fracture classification, the OR for type B fractures versus type A fractures was 0 (P > 0.9), while for type C fractures versus type A fractures, the OR was 0.15 (95% CI: 0.02, 1.00), P = 0.069. Finally, the Johner-Wruhs score for excellent-to-good outcomes was analysed as an outcome variable using logistic regression. Independent variables included temporary fixation method, sex, age, laterality of injury, cause of injury, fracture location, AO fracture classification, pre-hospital delay, presence of open fractures, and VAS pain score. In the univariate analysis, both temporary fixation method and AO fracture classification were significant (P < 0.1, see Table 5). Stepwise regression was performed, resulting in stepwise model 1. A full model was then built with all relevant factors and subjected to stepwise selection, yielding stepwise model 2, which included only AO fracture classification. AIC comparisons were performed, and the model with the lowest AIC value was selected as the optimal model. In this model, the OR for type B fractures versus type A fractures was 1.26 (95% CI: 0.22, 7.38), P = 0.8, while for type C fractures versus type A fractures, the OR was 0.27 (95% CI: 0.06, 1.01), P = 0.069. 2.3 Definitive Surgical Outcomes for Severe Lower Leg Injuries in the Three Groups The results of the linear regression analysis for peak creatine kinase (CK) levels showed that the difference between the calcaneal traction group and the external traction fixation group was -115 (95% CI: -391.02, 161), p = 0.41. The difference between the external skeletal fixation group and the external traction fixation group was 278 (95% CI: 1.34, 554), p = 0.049. The results of the linear regression analysis for peak lactate levels indicated that the difference between the calcaneal traction group and the external traction fixation group was 0.517 (95% CI: 0.190, 0.844), p < 0.01, while the difference between the external skeletal fixation group and the external traction fixation group was 0.341 (95% CI: 0.007, 0.67), p = 0.046. The mean duration of definitive surgery for the three groups was 69 ± 17 minutes, 89 ± 15 minutes, and 88 ± 15 minutes, respectively. Based on the selected optimal model, the marginal effect differences between the groups were compared. The difference in definitive surgery duration between the calcaneal traction group and the external traction fixation group was 20.60 minutes (95% CI: 12.76, 28.45), p < 0.001, while the difference between the external skeletal fixation group and the external traction fixation group was 19.59 minutes (95% CI: 11.62, 27.50), p < 0.001. The postoperative infection rates for the three groups were 6.7%, 3.1%, and 23%, respectively. The odds ratio (OR) for infection rates in the calcaneal traction group compared to the external traction fixation group was 0.48 (95% CI: 0.02, 6.44), p = 0.6, with a risk difference (RD) of -0.05 (95% CI: -0.26, 0.15), p = 0.61. The OR for infection rates in the external skeletal fixation group compared to the external traction fixation group was 5.59 (95% CI: 0.85, 60.90), p = 0.1, with an RD of 0.29 (95% CI: -0.02, 0.61), p = 0.07. The proportion of unplanned secondary surgeries in the three groups was 3.3%, 6.3%, and 17%, respectively. The OR for unplanned secondary surgeries in the calcaneal traction group compared to the external traction fixation group was 7.27 (95% CI: 0.37, 300), p = 0.2, with an RD of 0.05 (95% CI: -0.05, 0.15), p = 0.31. The OR for unplanned secondary surgeries in the external skeletal fixation group compared to the external traction fixation group was 11.8 (95% CI: 1.23, 310), p = 0.06, with an RD of 0.09 (95% CI: -0.04, 0.22), p = 0.18. At the final follow-up, the Johner-Wruhs excellent-to-good rating was 93%, 79%, and 73% for the three groups, respectively. The OR for achieving an excellent-to-good Johner-Wruhs score in the calcaneal traction group compared to the external traction fixation group was 0.26 (95% CI: 0.04, 1.17), p = 0.11, with an RD of -0.15 (95% CI: -0.32, 0.02), p = 0.08. The OR for achieving an excellent-to-good Johner-Wruhs score in the external skeletal fixation group compared to the external traction fixation group was 0.20 (95% CI: 0.03, 0.88), p = 0.05, with an RD of -0.20 (95% CI: -0.38, -0.02), p = 0.03. The results are presented in Table 6. Conclusion: The external traction fixation scaffold configuration is a practical technical choice for early limb stabilization in severe lower leg injuries. Discussion 3.1 The results of this study indicate that external traction fixation demonstrates a high level of safety in the early-stage treatment of severe limb injuries . 3.1.1. Muscle Tissue Safety Under Tension During External traction fixation Treatment In the early-stage treatment of limb injuries, the prolonged tensile mechanical environment to which the injured limb is subjected raises concerns about muscle tissue safety. Marson and Baldwin [20] suggested that creatine kinase (CK) is an important indicator of skeletal muscle injury, while initial post-traumatic lactate levels are also associated with skeletal muscle damage. Oladipo et al. [21] found that elevated initial lactate levels in trauma patients undergoing lower limb long bone fracture fixation were correlated with postoperative complications, prolonged hospitalization, and increased hospital costs. In this study, the early peak CK levels in the external traction fixation group displayed significant individual variation. Although the estimated effect size of the intervention was large, the confidence interval was wide, leading to statistical insignificance. However, lactate levels in the external traction fixation group were lower than those in both the calcaneal traction and external skeletal fixation groups. This could be attributed to the pin insertion sites in external traction fixation being located away from the fracture zone, thereby avoiding direct invasion of muscle tissue in the fracture area and preventing additional iatrogenic damage to the muscles within the compartment. Furthermore, compared to calcaneal traction and external skeletal fixation, external traction fixation may reduce secondary soft tissue injury around the fracture under sustained traction tension. This suggests that external traction fixation may offer better early protection for skeletal muscle and soft tissue compared to calcaneal traction. 3.1.2. High Safety of Pin Tract Management During Treatment The early-stage treatment of severe lower leg injuries often requires external fixation, which has become a widely accepted approach [7, 22-24]. However, the technique of pin placement remains controversial. Bible et al. [10] recommended choosing anatomical regions with minimal soft tissue coverage for pin insertion. Additionally, insertion into epiphyseal cancellous bone is technically easier than cortical bone placement. Studies have shown that thermal damage from drilling at the time of pin insertion is associated with pin loosening, with the maximum temperature and duration of heating being key influencing factors. Pre-drilling before inserting the pin has been shown to significantly reduce thermal damage [25]. In the external traction fixation group, pins were inserted into the cancellous bone of the bone ends, resulting in lower thermal damage to the pin tract, thereby reducing the likelihood of pin loosening. Compared to external skeletal fixation, external traction fixation eliminates the need for near fracture-line site pin placement, reducing the overall incidence of pin tract infections. Furthermore, because pin insertion sites are positioned away from the definitive surgery area, even if pin tract infection occurs, it does not compromise the definitive surgery. Therefore, the findings suggest that traction-based pin insertion is a safe technique that can effectively reduce the incidence of pin tract infections after definitive surgery. This study supports the conclusion that external traction fixation is a safe temporary fixation method when applied within an appropriate range of tissue tension. 3.2 This study also demonstrated that external traction fixation is an efficient method for temporary limb stabilization . 3.2.1. High Reduction Efficiency This type of external fixation can function as a fracture reduction device during the early fixation period. Zhang Yingze et al. previously applied the “bidirectional device” for rapid assisted reduction in lower limb long bone fractures, achieving minimally invasive surgical outcomes. During the traction phase and definitive surgery, bidirectional device traction can be used to maintain fracture reduction, assisting in the completion of intramedullary nailing or minimally invasive plate fixation. External traction fixation not only temporarily stabilizes the injured limb during staged treatment of severe lower leg injuries but also provides muscle tension control, mechanical axis stability, pain relief, and ease of mobilization. Additionally, the circular support provided by the device to the fracture site minimizes soft tissue swelling and reduces the risk of compartment syndrome. Throughout the treatment period, patients in the external traction fixation group reported significantly lower pain scores compared to the other two groups, indicating a higher level of subjective comfort. During definitive surgery, external traction fixation-maintained fracture reduction, thereby facilitating the completion of intramedullary nailing or minimally invasive plate osteosynthesis (MIPO). Due to adequate and effective fracture reduction, the reduction step was no longer required during definitive surgery in this group, resulting in a significantly shorter surgery duration compared to the other two groups. In contrast, the calcaneal traction group faced limitations due to inconsistent and insufficient traction forces, leading to soft tissue contractures, which increased the difficulty of fracture reduction during definitive internal fixation surgery, ultimately prolonging surgical duration. Linear regression analysis confirmed that the temporary fixation method significantly influenced definitive surgery duration. 3.2.2. High Efficiency in Protecting the Periosteum and Soft Tissues According to the AO Organization [11], external fixation devices used for damage control orthopaedic (DCO) surgery should be placed outside the injury zone and, ideally, should not interfere with the area designated for definitive surgery. The high-spanning configuration of external traction fixation fully aligns with AO principles, providing ample space for surgical incision selection and demonstrating high compatibility with definitive surgery. This study also confirmed that external traction fixation can be retained during definitive surgery, assisting in fracture reduction for minimally invasive plate osteosynthesis (MIPO) or tibial intramedullary nailing techniques. This approach significantly reduces the duration of definitive internal fixation surgery, and the reserved soft tissue pathway does not interfere with implant placement. The significantly shorter definitive surgery time in the external traction fixation group compared to the control groups suggests that this temporary fixation method is highly compatible with definitive surgery. Compared to calcaneal traction and external skeletal fixation, external traction fixation demonstrates superior periosteal and soft tissue protection and greater compatibility with definitive surgical procedures, ultimately contributing to faster fracture healing. Based on final treatment outcomes and patient comfort during the treatment process, external traction fixation proves to be a practical and effective temporary fixation method. 3.3 Observational Period for Early Treatment In this study, the early-stage treatment observation period was generally controlled within 7 days, based on the following considerations: 1. Severe complications such as compartment syndrome typically develop within 48 to 72 hours. After 5 to 7 days of observation, a clear diagnosis can usually be established, allowing for the formulation of a definitive surgical plan. 2. Patients with shock, traumatic brain injury, or chest trauma often require 7 to 10 days for systemic stabilization, necessitating an adequate observation period. 3. Elderly trauma patients often require additional time for preoperative assessment and management of underlying medical conditions, necessitating thorough preoperative preparation. The damage control orthopaedic (DCO) concept has been widely adopted worldwide, demonstrating positive clinical outcomes. It is generally accepted that when patients are at risk of the “lethal triad,” performing early definitive internal fixation is too risky, necessitating a staged surgical approach, where external fixation is applied first, followed by definitive internal fixation [3-5]. Oladipo et al. [21], in a large-scale retrospective clinical study, suggested that even in cases without life-threatening conditions, adopting a proactive staged treatment strategy for severe limb injuries—particularly in elderly patients, those with unclear medical histories, limited hospital blood reserves, or inadequate surgical expertise—can lead to better clinical outcomes [21, 26]. 3.4 Study Limitations This study has several limitations, including a small sample size and a single-centre design. Several outcome measures, such as peak CK, infection rates after definitive surgery, unplanned secondary surgery rates, and Johner-Wruhs excellent-to-good outcomes, did not reach statistical significance, likely due to insufficient sample size. Future studies will aim to expand the sample size and further validate these findings. Declarations Conflict of Interest Statement: All JTACS Disclosure forms have been supplied and are provided as supplemental digital content. Ethical Review Statement: This study was approved by the Medical Ethics Committee of the Air Force Hospital of Eastern Theatre Command (Approval Number: 20150513-018) . This study was conducted in accordance with the Declaration of Helsinki. As this was a retrospective analysis of anonymized clinical data, individual informed consent was waived by the Ethics Committee of the Air Force Hospital of Eastern Theatre Command. Author Contribution Statement Li Ying was responsible for the conceptualization, methodology, and supervision of the study. Yang Junsheng contributed to the methodology, data curation, investigation, original draft writing, and supervision. Yang Zhiwei contributed to the methodology, data curation, formal analysis, and original draft writing. Zhao Lei contributed to formal analysis and resource provision. Wang Zixu participated in the investigation. Xue Qing participated in the investigation. Sun Zhongyang participated in the investigation and original draft writing. Tong Liangsheng contributed to resource provision and methodology. Liu Jin contributed to formal analysis and manuscript review and editing. All authors have read and approved the final manuscript. Data Availability Declaration The datasets used and/or analysed during the current study are available from the corresponding author on reasonable request. Funding: No external funding was received for this study. Reference Higgin RP, Palmer J, Qureshi AA, Hancock NJ. Patient reported outcomes after definitive open tibial fracture management. Injury. 2022;53:3838-42. Mundi R, Chaudhry H, Niroopan G, Petrisor B, Bhandari M. Open Tibial Fractures: Updated Guidelines for Management. JBJS Rev. 2015;3. Tesso CB, Mohammed T, Teshome B, Ayalew K, Kebede S. Magnitude of infection and associated factors in open tibial fracture treated operatively, in Addis Ababa burn emergency and trauma center. Eur J Orthop Surg Traumatol. 2024;35:46. Blachut PA, Meek RN, O'Brien PJ. External fixation and delayed intramedullary nailing of open fractures of the tibial shaft. A sequential protocol. J Bone Joint Surg Am. 1990;72:729-35. Horst K, Andruszkow H, Weber C, Dienstknecht T, Hildebrand F, Tarkin I, et al. Standards of external fixation in prolonged applications to allow safe conversion to definitive extremity surgery: the Aachen algorithm for acute ex fix conversion. Injury. 2015;46 Suppl 3:S13-8. Kucukdurmaz F, Alijanipour P. Current Concepts in Orthopedic Management of Multiple Trauma. Open Orthop J. 2015;9:275-82. Guerado E, Bertrand ML, Cano JR, Cervan AM, Galan A. Damage control orthopaedics: State of the art. World J Orthop. 2019;10:1-13. Ziran BH, Smith WR, Anglen JO, Tornetta P, 3rd. External fixation: how to make it work. J Bone Joint Surg Am. 2007;89:1620-32. Eriksson A, Albrektsson T, Grane B, McQueen D. Thermal injury to bone. A vital-microscopic description of heat effects. Int J Oral Surg. 1982;11:115-21. Bible JE, Mir HR. External Fixation: Principles and Applications. J Am Acad Orthop Surg. 2015;23:683-90. Mukhopadhaya J, Jain AK. AO Principles of Fracture Management. Indian Journal of Orthopaedics. 2019;53:217-8. Michael DS, Ali A, Joseph KA, John C, Geoffrey SM. Safety of Skeletal Traction through the Distal Femur, Proximal Tibia, and Calcaneus. Archives of Trauma Research. 2019;8:198-202. Tri Sastra Pradhini DP. Skeletal Traction: an Overview of Techniques, Indications, and Considerations. Lombok Medical Journal. 2024. Datumanong-Mala. ND. NURSING MANAGEMENT OF COMPLICATIONS IN PATIENTS WITH SKELETAL TRACTION. Int J of Adv Res. 2019. Schade AT, Sabawo M, Nyamulani N, Mpanga CC, Ngoie LB, Metcalfe AJ, et al. Functional outcomes and quality of life at 1-year follow-up after an open tibia fracture in Malawi: a multicentre, prospective cohort study. Lancet Glob Health. 2023;11:e1609-e18. Chen W, Zhang T, Wang J, Liu B, Hou Z, Zhang Y. Minimally invasive treatment of displaced femoral shaft fractures with a rapid reductor and intramedullary nail fixation. Int Orthop. 2016;40:167-72. Guo J, Yin Y, Jin L, Zhang R, Hou Z, Zhang Y. Acute compartment syndrome: Cause, diagnosis, and new viewpoint. Medicine (Baltimore). 2019;98:e16260. Osborn CPM, Schmidt AH. Management of Acute Compartment Syndrome. J Am Acad Orthop Surg. 2020;28:e108-e14. Johner R, Wruhs O. Classification of tibial shaft fractures and correlation with results after rigid internal fixation. Clin Orthop Relat Res. 1983:7-25. Marson JW, Baldwin HE. The creatine kinase conundrum: a reappraisal of the association of isotretinoin, creatine kinase, and rhabdomyolysis. Int J Dermatol. 2020;59:279-83. Oladipo V, Portney D, Haber J, Baker H, Strelzow J. Lactic acid levels are associated with morbidity, length of stay, and total treatment costs in urban trauma patients with lower extremity long bone fractures. Eur J Orthop Surg Traumatol. 2024;34:1963-70. Yakkanti M, Mauffrey C, Roberts CS. Limb Damage Control Orthopedics. Springer London; 2012. p. 29-41. De Coster T. Timing and Strategies for Definitive Fixation After a Damage Control Frame. Springer London; 2012. p. 185-209. Matsumura T, Takahashi T, Miyamoto O, Saito T, Kimura A, Takeshita K. Clinical outcome of conversion from external fixation to definitive internal fixation for open fracture of the lower limb. J Orthop Sci. 2019;24:888-93. Matthews LS, Green CA, Goldstein SA. The thermal effects of skeletal fixation-pin insertion in bone. J Bone Joint Surg Am. 1984;66:1077-83. Haller JM, Holt D, Rothberg DL, Kubiak EN, Higgins TF. Does Early versus Delayed Spanning External Fixation Impact Complication Rates for High-energy Tibial Plateau and Plafond Fractures? Clin Orthop Relat Res. 2016;474:1436-44. Tables Tables 1 to 6 are available in the Supplementary Files section Additional Declarations No competing interests reported. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6934471","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":474755276,"identity":"2783f692-96b1-4af6-9827-496ac4184cbe","order_by":0,"name":"Junsheng Yang","email":"","orcid":"","institution":"Air Force Hospital from Eastern Theatre Command","correspondingAuthor":false,"prefix":"","firstName":"Junsheng","middleName":"","lastName":"Yang","suffix":""},{"id":474755277,"identity":"028416df-253e-4eb9-a2ed-047d27e2b67c","order_by":1,"name":"Zhiwei Yang","email":"","orcid":"","institution":"Air Force Hospital from Eastern Theatre Command","correspondingAuthor":false,"prefix":"","firstName":"Zhiwei","middleName":"","lastName":"Yang","suffix":""},{"id":474755278,"identity":"6735a77f-3064-4959-ada4-84224e5a005e","order_by":2,"name":"Lei Zhao","email":"","orcid":"","institution":"Air Force Hospital from Eastern Theatre Command","correspondingAuthor":false,"prefix":"","firstName":"Lei","middleName":"","lastName":"Zhao","suffix":""},{"id":474755279,"identity":"275b8c29-dd5a-4fa1-9e89-22e4a0dd7ce2","order_by":3,"name":"Zixu Wang","email":"","orcid":"","institution":"Air Force Hospital from Eastern Theatre Command","correspondingAuthor":false,"prefix":"","firstName":"Zixu","middleName":"","lastName":"Wang","suffix":""},{"id":474755280,"identity":"6670a1a9-62ac-4b20-9ba4-8422b83ec022","order_by":4,"name":"Qing Xue","email":"","orcid":"","institution":"Air Force Hospital from Eastern Theatre Command","correspondingAuthor":false,"prefix":"","firstName":"Qing","middleName":"","lastName":"Xue","suffix":""},{"id":474755281,"identity":"a1f7fc67-de18-4341-bfb4-cb473359a03b","order_by":5,"name":"Zhongyang Sun","email":"","orcid":"","institution":"Air Force Hospital from Eastern Theatre Command","correspondingAuthor":false,"prefix":"","firstName":"Zhongyang","middleName":"","lastName":"Sun","suffix":""},{"id":474755282,"identity":"cfa52bde-70b8-4a97-83c9-eda2405e5e5c","order_by":6,"name":"Liangcheng Tong","email":"","orcid":"","institution":"Air Force Hospital from Eastern Theatre Command","correspondingAuthor":false,"prefix":"","firstName":"Liangcheng","middleName":"","lastName":"Tong","suffix":""},{"id":474755283,"identity":"b72c81c6-c541-4b15-a193-ab7fac8b399e","order_by":7,"name":"Jin Liu","email":"","orcid":"","institution":"The First Affiliated Hospital of Nanjing Medical University, Jiangsu Province Hospital","correspondingAuthor":false,"prefix":"","firstName":"Jin","middleName":"","lastName":"Liu","suffix":""},{"id":474755284,"identity":"bcc2e3e4-640c-4e0e-9f2f-11a43904dd37","order_by":8,"name":"Ying Li","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA10lEQVRIie3QMQrCMBSA4SdCXIo4vlDIDYRIoeDSXqWhUNeOukWEuHiB4j3EMSK0Sw9Q0aG9QQ8gaMQDNKNgvuFN74e8ADjOL2oIcPokgJPttuutk6WcAnrXXYC2CWwkA8SVmnk2xfSukvx2DqOi6BQgRGwuBxL6KPWiqLP06AvV5pAGoR5IeLOSAZIyZb7YcwQtTlbJk7xSRi8KPbsk05wqEvk4skzMLQnHmiT0IMwnc4tbzI+FHNckxqrqun4dscHEINwMIb/vHF7/GLdmxHa7juM4f+kNLpJGXUU8JYIAAAAASUVORK5CYII=","orcid":"","institution":"Air Force Hospital from Eastern Theatre Command","correspondingAuthor":true,"prefix":"","firstName":"Ying","middleName":"","lastName":"Li","suffix":""}],"badges":[],"createdAt":"2025-06-20 02:23:10","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6934471/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6934471/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":85924470,"identity":"e04aa968-afd5-4de9-870f-6165bdd4b80a","added_by":"auto","created_at":"2025-07-03 08:26:27","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":79686,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eCase data collection Flowchart\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-6934471/v1/dfdc684d687794fd10132e37.png"},{"id":85924471,"identity":"11690ac5-2bec-4ef7-9221-8c46674fa4b6","added_by":"auto","created_at":"2025-07-03 08:26:27","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":247896,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eSchematic Diagram of Fixation Methods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e(a) Fracture and soft tissue injury area. (b) Soft tissue tension distribution after trauma. (c, d) External traction fixation configuration and the mechanism of reverse soft tissue tension maintaining temporary fracture stability. (e) Traditional calcaneal traction. (f) Traditional external skeletal fixation.\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-6934471/v1/967912a7ae66ef6e28d1e25e.png"},{"id":85924472,"identity":"ad46a0ba-fcea-46f2-a9d8-dc1249c880b1","added_by":"auto","created_at":"2025-07-03 08:26:27","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":539933,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eCase Presentation of a 51-Year-Old Male Patient with an Open Tibia and Fibula Fracture (Gustilo IIIA) Due to a Traffic Accident\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e(a) Clinical photograph of the injured limb post-trauma. (b) X-ray image immediately after injury. (c) Photograph after external traction fixation. (d) X-ray image after external traction fixation. (e) Conversion to intramedullary nailing 15 days after damage control, with the external fixation device retained intraoperatively for assistance. (f) Immediate postoperative X-ray image. (g) X-ray image at 17 months postoperatively showing fracture healing. (h) Limb function at the final follow-up.\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-6934471/v1/2ba4ba60781363ffd03b4995.png"},{"id":85924473,"identity":"3b75d4b9-4194-477a-b996-2330c12c5852","added_by":"auto","created_at":"2025-07-03 08:26:27","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":449625,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eCase Presentation of a 47-Year-Old Male Patient with a Left Tibia and Fibula Fracture with Skin Contusion and Left Heel Skin Laceration Due to a Motorcycle Accident\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e(a) Clinical photograph of the injured limb post-trauma. (b) X-ray image immediately after injury. (c) Clinical photograph after external traction fixation. (d) X-ray image after temporary external traction fixation. (e) Conversion to tibial intramedullary nailing 19 days after damage control. (f) X-ray image after definitive fracture fixation. (g) Functional outcome at 1-year postoperative follow-up. (h) X-ray image at 16 months postoperatively showing fracture healing.\u003c/p\u003e","description":"","filename":"4.png","url":"https://assets-eu.researchsquare.com/files/rs-6934471/v1/75141a8f0e011e8aec4386ad.png"},{"id":85925135,"identity":"eaf5ec58-c6f3-4101-8c62-93373e70bca8","added_by":"auto","created_at":"2025-07-03 08:34:28","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2747343,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6934471/v1/425374f0-7401-4900-812b-aa041f3e66c0.pdf"},{"id":85924469,"identity":"a57fe5ee-3e6e-448c-8ee7-8ed23d3410b3","added_by":"auto","created_at":"2025-07-03 08:26:27","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":60058,"visible":true,"origin":"","legend":"","description":"","filename":"Tables.docx","url":"https://assets-eu.researchsquare.com/files/rs-6934471/v1/d717672ff4157ae47605fc89.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Preliminary exploration of safety and efficiency of external traction fixation in early-stage treatment of severe lower leg injuries--A retrospective cohort study","fulltext":[{"header":"Background","content":"\u003cp\u003eSevere limb injuries (SLI) refer to limb damage caused by high-energy trauma, which can result in comminated fractures as well as severe muscle and skin contusions. The lower leg, in particular, has a unique anatomical structure, and following a severe limb injury, the early-stage condition and prognosis are highly uncertain. Complications such as compartment syndrome, bone and soft tissue infections, and a high disability rate may occur\u0026nbsp;[1-3]. Blachut\u0026nbsp;[4]\u0026nbsp;and Horst\u0026nbsp;[5]\u0026nbsp;have suggested that active staged surgery is an effective treatment strategy. In the early phase of trauma, damage control surgical techniques can be used to achieve temporary stabilization of the injured limb, providing a time window for monitoring changes in the limb’s condition. Additionally, better preoperative preparation can improve the quality of definitive surgery, leading to better functional outcomes for the limb. In the overall staged treatment of limb injuries, the safety and efficacy of early-stage treatment techniques play a crucial role in determining the final therapeutic outcome\u0026nbsp;[6, 7].\u003c/p\u003e\n\u003cp\u003eAmong the early temporary fixation methods for limbs, external skeletal fixation is the most commonly used technique. Traditional external skeletal fixation emphasizes to purchase each bone fragments by using pins connected with rods to achieve fracture stability. However, placing fixation pins within the fracture area may further aggravates soft tissue damage in the injured region, and bacteria can invade the bone and soft tissues through the pin track, leading to secondary infections. According to Ziran et al.\u0026nbsp;[8], excessive movement of muscles and skin around the fracture can trigger local inflammation, ultimately causing pin track infections. Bone tissue may undergo irreversible changes, including osteocyte necrosis and alkaline phosphatase inactivation\u0026nbsp;[9]. Additionally, because external skeletal fixation involves placing pins near the fracture site, there is a higher risk of pin track infections, which can compromise definitive internal fixation surgery\u0026nbsp;[10, 11].\u003c/p\u003e\n\u003cp\u003eCalcaneal traction is a traditional method of temporary fracture fixation that generally involves inserting a traction pin into the epiphyseal cancellous bone. This technique is simple and avoids placing fixation pins in the injury zone, reducing the risk of pin track infections compared to external skeletal fixation\u0026nbsp;[12]. However, its disadvantages include instability in the traction force direction, which may cause secondary displacement of the fracture and further soft tissue damage\u0026nbsp;[13]. Prolonged calcaneal traction can also lead to irregular changes in soft tissue tension around the fracture site due to patient repositioning, resulting in poor fixation effectiveness. Furthermore, because calcaneal traction requires connection to a traction frame, both the patient and the injured limb are immobilized, causing discomfort and reducing fracture stability during the fixation period\u0026nbsp;[14].\u003c/p\u003e\n\u003cp\u003eExternal traction fixation is another commonly used limb stabilization technique. Schade et al.\u0026nbsp;[15]\u0026nbsp;applied this type of external fixation to the early reduction and fixation of tibia and fibula fractures, suggesting that it can be combined with plaster fixation as a treatment strategy in resource-limited settings. Yingze Zhang et al.\u0026nbsp;[16]\u0026nbsp;proposed the concept of the “rapid reduction device” utilizing a\u0026nbsp;“bidirectional traction”\u0026nbsp;mechanism. This device enables early fracture reduction and can also be used during definitive surgery to maintain reduction and assist in internal fixation procedures. By applying axial traction along the limb’s mechanical axis, this technique provides early relative stability to the limb.\u003c/p\u003e\n\u003cp\u003eIn our study, we modified the pin placement and structure of external fixation devices based on the principles of external skeletal fixation, incorporating the concept of traction to achieve temporary fracture fixation. We define this technique as external traction fixation, which expands the “bidirectional\u0026nbsp;traction” concept to the early-stage treatment of severe limb injuries. By using external fixation with traction, fractures can be reduced and the injured limb temporarily stabilized in the early trauma stage, allowing for definitive surgery when conditions are appropriate. This method enables patient mobility during traction, while also addressing the invasiveness issues associated with external skeletal fixation pins.\u003c/p\u003e\n\u003cp\u003eAlthough external traction fixation is commonly used for early fracture reduction and has seen some clinical application, there has been no systematic study evaluating its long-term effectiveness and safety in early-stage temporary fixation for severe limb injuries.\u003c/p\u003e\n\u003cp\u003eIn this study, we conducted a retrospective cohort analysis to investigate and compare the safety and efficacy of external traction fixation, calcaneal traction, and external skeletal fixation, in stabilizing the injured limb during the early stage of trauma.\u003c/p\u003e"},{"header":"Clinical Data and Methods","content":"\u003cp\u003e\u003cstrong\u003e1.1 Study Population\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study retrospectively analysed 236 cases of severe lower leg injuries treated at the Air Force Hospital of the Eastern Theatre Command from May 2016 to May 2022.According to the following inclusion and exclusion criteria, a total of 92 patients were enrolled in the cohort study on early-stage treatment of severe lower leg injuries. The inclusion and exclusion flowchart are shown in Figure 1.\u003c/p\u003e\n\u003cp\u003eThe\u0026nbsp;inclusion criteria\u0026nbsp;required patients to be\u0026nbsp;18 years or older\u0026nbsp;and diagnosed with\u0026nbsp;severe lower leg injuries, including\u0026nbsp;tibial (fibular) comminated fractures\u0026nbsp;accompanied by\u0026nbsp;skin and soft tissue envelop\u0026nbsp;or complicated by\u0026nbsp;compartment syndrome\u0026nbsp;[17, 18]. Additionally, patients with\u0026nbsp;open fractures of the tibia and fibula, where the fracture line extended to the\u0026nbsp;knee or ankle joint surfaces, were eligible if they were scheduled for\u0026nbsp;planned staged treatment\u0026nbsp;[5]. The study focused on three early-stage\u0026nbsp;temporary fixation methods:\u0026nbsp;external traction fixation, calcaneal traction, and external skeletal fixation. To be included, patients were also required to have a\u0026nbsp;follow-up period of at least 12 months\u0026nbsp;after undergoing\u0026nbsp;definitive internal fixation surgery.\u003c/p\u003e\n\u003cp\u003ePatients were excluded if they were unable to cooperate with treatment due to mental illness or related symptoms. Additionally, cases with missing key study data were omitted from the final analysis.\u003c/p\u003e\n\u003cp\u003eThe study cohort included 92 patients, whose baseline characteristics are detailed in Table 1. Among the three treatment groups, the proportion of male patients was 83% in the external traction fixation group, 69% in the calcaneal traction group, and 83% in the external skeletal fixation group. The mean age (\u0026plusmn; standard deviation) for each group was 47 \u0026plusmn; 15 years in the external traction fixation group, 47 \u0026plusmn; 11 years in the calcaneal traction group, and 46 \u0026plusmn; 13 years in the external skeletal fixation group.\u003c/p\u003e\n\u003cp\u003eThe\u0026nbsp;causes of injury\u0026nbsp;varied among patients, with\u0026nbsp;traffic accidents accounting for 54 cases, while\u0026nbsp;falls contributed to 38 cases. Regarding\u0026nbsp;fracture locations, the study population included\u0026nbsp;26 cases of tibial plateau fractures,\u0026nbsp;38 cases of tibial shaft fractures, and\u0026nbsp;28 cases of distal tibial fractures.\u003c/p\u003e\n\u003cp\u003eThe proportion of\u0026nbsp;open fractures\u0026nbsp;was relatively high across all groups. Specifically,\u0026nbsp;70% of patients in the external traction fixation group,\u0026nbsp;78% in the calcaneal traction group, and\u0026nbsp;80% in the external skeletal fixation group\u0026nbsp;had open fractures.\u003c/p\u003e\n\u003cp\u003eThe selection of\u0026nbsp;early-stage treatment methods, including\u0026nbsp;external traction fixation, calcaneal traction, and external skeletal fixation, was determined by\u0026nbsp;a consistent team of treating physicians\u0026nbsp;to minimize variability in clinical decision-making. The distribution of patients within each treatment category was\u0026nbsp;30 cases in the external traction fixation group (Group A),\u0026nbsp;32 cases in the calcaneal traction group using a calcaneal pin (Group B), and\u0026nbsp;30 cases in the external skeletal fixation group (Group C).\u003c/p\u003e\n\u003cp\u003ePatients admitted to our hospital with severe lower leg injuries between May 2016 and May 2021 were retrospectively enrolled. Inclusion criteria were: (1) fresh, closed or Gustilo type I/II open fractures of the tibia and/or fibula; (2) age between 18 and 75 years; and (3) receipt of temporary fracture stabilization using one of three methods \u0026mdash; external traction fixation, calcaneal traction, or external skeletal fixation \u0026mdash; within 48 hours of injury. Patients were excluded if key clinical indicators were missing, or follow-up was incomplete. Specifically, 3 patients were transferred to local hospitals due to financial or insurance limitations, 2 patients died within one year of injury, 4 were transferred to internal medicine specialties due to acute comorbidities, and 6 were lost to follow-up despite multiple contact attempts. Additionally, 3 patients with post-traumatic neuropsychiatric disorders were unable to cooperate with treatment. These exclusions were determined to be random and unrelated to clinical outcomes, suggesting minimal risk of selection bias.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1.2 Limb Fixation Methods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eA group: External traction fixation Group\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe external traction fixation group utilized an external fixation device to achieve temporary limb stabilization through a traction-based mechanism. This method involved a systematic approach to positioning, disinfection, pin placement, and fixation to ensure effective fracture stabilization while minimizing soft tissue damage.\u003c/p\u003e\n\u003cp\u003eThe procedure began with patient positioning, where the injured individual was placed in a supine position with the affected limb elevated. This positioning facilitated both surgical access and traction application. Following positioning, disinfection was performed using hydrogen peroxide and diluted povidone-iodine, ensuring a sterile environment. A pulsed irrigation system was employed to thoroughly cleanse the wound, reducing contamination risk. Subsequently, routine surgical field preparation was conducted, including standard surgical disinfection and the application of a sterile drape.\u003c/p\u003e\n\u003cp\u003ePin placement played a crucial role in the success of external traction fixation. The most common skeletal traction sites selected for pin insertion included the calcaneal tuberosity and tibial tuberosity. The specific insertion points varied based on anatomical landmarks. For the calcaneal region, a 5 mm pin was inserted from the medial to lateral direction, with the entry point positioned at the midpoint of the line between the medial malleolus and the calcaneal tuberosity. The pin was then drilled outward through the lateral side. Meanwhile, for the tibial tuberosity region, a 5 mm pin was inserted in a lateral-to-medial direction, or tow 5 mm pins were individually placed laterally and medially, with the entry point located 3 cm lateral to the tibial tuberosity midline. The length of the medial and lateral pin ends outside of the skin was carefully adjusted to remain approximately equal, ensuring proper stability.\u003c/p\u003e\n\u003cp\u003eOnce the pins were in place, the fixation process commenced. Two assistants held the tibial tuberosity pin and calcaneal pin, carefully correcting rotational deformities while applying counter-traction along the tibial mechanical axis. To ensure rigid and effective stabilization, pin-rod clamps were used to connect two carbon fibber rods to the external fixation pins, thereby maintaining traction. If any open wounds were present, additional debridement and wound closure were performed to prevent infection and facilitate proper healing. Following the procedure, the pulsation of the dorsalis pedis artery was assessed to confirm adequate vascular perfusion, either by manual palpation or through Doppler ultrasound examination.\u003c/p\u003e\n\u003cp\u003eThe external traction fixation device was designed with several structural features to enhance its effectiveness. Firstly, pin placement was prioritized in the epiphyseal region to minimize soft tissue damage. Secondly, the technique utilized the soft tissue splinting principle, leveraging traction tension to achieve limb stabilization. Lastly, the pin placement strategy ensured that pins were inserted away from the injury zone and definitive surgery site, thereby protecting soft tissues and reducing the risk of iatrogenic injury.\u003c/p\u003e\n\u003cp\u003e(Refer to Figure 2 for schematic diagrams of external traction fixation, calcaneal traction, and external skeletal fixation. Additionally, Figures 3 and 4 provide illustrative case examples.)\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eB group: Calcaneal traction Group\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe calcaneal traction group employed calcaneal traction as the primary method of temporary immobilization (Figure 2). To begin the procedure, local anaesthesia was administered to minimize patient discomfort. Following anaesthesia, the surgical site was sterilized, and sterile draping was applied. If open wounds were present, wound debridement and suturing were performed to mitigate infection risks.\u003c/p\u003e\n\u003cp\u003ePin placement for calcaneal traction involved precise entry point selection. The entry site was identified as the midpoint of the line connecting the medial malleolus and the calcaneal tuberosity. A Schanz pin was then inserted in a horizontal direction, penetrating the calcaneus from medial to lateral.\u003c/p\u003e\n\u003cp\u003eOnce the traction pin was securely positioned, a traction bow was installed onto the Schanz pin. The traction bow was then connected to a pulley system at the foot of the bed via traction cords, applying a traction force of 4\u0026ndash;6 kg. This setup allowed for gradual and controlled limb stabilization, facilitating soft tissue recovery and fracture management.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eC group: External skeletal fixation Group\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe external skeletal fixation group underwent temporary fracture stabilization through a standard pin-rod external fixation technique (Figure 2). The procedure began with patient positioning, where the individual was placed in a supine position. To ensure a sterile operative field, the injury site was thoroughly disinfected and irrigated according to standard surgical protocols.\u003c/p\u003e\n\u003cp\u003eThe pin placement strategy was crucial in ensuring fracture stability. Two sets of fixation pins were inserted into the proximal and distal main fracture fragments, with at least two pins per set to optimize mechanical support. Specifically, the near fracture-line pins were positioned 3\u0026ndash;5 cm away from the fracture line, while the far fracture-line pins were placed as far apart as possible from the near pins to maximize stability.\u003c/p\u003e\n\u003cp\u003eFollowing pin insertion, the final fixation process was performed. Short rods and clamps were used to connect the proximal and distal set of pins, ensuring that the fracture was properly aligned. Once alignment was confirmed, the fixation system was securely locked in place, providing immediate structural support for the injured limb.\u003c/p\u003e\n\u003cp\u003eThis method of external skeletal fixation was particularly effective in achieving temporary fracture stability while allowing for subsequent definitive surgical interventions.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1.3 Functional Evaluation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo comprehensively assess the outcomes of early-stage temporary fixation methods, a range of clinical indicators were recorded and analysed. These evaluations focused on both short-term physiological responses and long-term functional recovery, ensuring a thorough understanding of the effectiveness of external traction fixation, calcaneal traction, and external skeletal fixation in the treatment of severe lower leg injuries.\u003c/p\u003e\n\u003cp\u003eOne of the primary parameters assessed was muscle damage, which was quantified by measuring peak creatine kinase (CK) and lactate levels within 48 hours of hospital admission. Creatine kinase serves as a biochemical marker of muscle injury, while lactate levels indicate tissue perfusion and metabolic stress, both of which are crucial in evaluating the degree of trauma sustained by the affected limb.\u003c/p\u003e\n\u003cp\u003ePain levels were also meticulously recorded to gauge patient discomfort and procedural effectiveness. The Visual Analog Scale (VAS) pain score, a widely used pain assessment tool, was employed to determine the peak pain levels within 48 hours after temporary fixation. Higher VAS scores were indicative of greater patient distress, providing insight into the relative comfort offered by each fixation method.\u003c/p\u003e\n\u003cp\u003eBeyond these physiological markers, key\u0026nbsp;hospitalization-related factors\u0026nbsp;were documented. These included\u0026nbsp;pre-hospital delay (time from injury to hospital admission), the duration of the temporary fixation procedure, the interval between temporary fixation and definitive surgery, and the total duration of definitive internal fixation surgery. These factors were essential in evaluating\u0026nbsp;the efficiency of each fixation technique, as shorter fixation and surgery times often correlate with\u0026nbsp;better patient outcomes and reduced surgical burden.\u003c/p\u003e\n\u003cp\u003eLong-term functional recovery was evaluated through scheduled follow-ups, beginning two weeks after definitive surgery. Subsequent evaluations were conducted at six weeks, three months, and every six weeks thereafter until fracture healing was confirmed. At the final follow-up, patient outcomes were systematically assessed using the Johner-Wruhs scoring system, a widely recognized standard for evaluating lower limb functional recovery. The Johner-Wruhs criteria for evaluating outcomes of tibial shaft fractures categorize results into four grades\u0026mdash;excellent, good, fair, and poor\u0026mdash;based on the assessment of fracture healing, neurovascular injury, deformity, joint mobility, pain, gait, and the ability to perform daily activities [19].\u003c/p\u003e\n\u003cp\u003eSex and age were obtained from ID information at admission. Injury side and cause were documented in the present illness history. Fracture site, AO classification, and open fracture grade were determined by a team of physicians based on radiographic interpretation. Pre-hospital time, defined as the interval from injury to emergency department arrival, was extracted from ambulance transfer records. Temporary fixation time and definitive surgery duration were obtained from surgical records. Laboratory values such as lactate and CK were measured using standard equipment (CK: Hitachi 7600-020 automatic biochemical analyzer; lactate: Radiometer ABL90 FLEX blood gas analyzer). VAS scores were recorded in nursing notes.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1.4 Statistical Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eStatistical analyses were conducted using R software (version 4.3.2) to ensure rigorous and accurate evaluation of the study\u0026rsquo;s findings. The statistical approach varied based on the nature of the data, with different methods applied for continuous and categorical variables.\u003c/p\u003e\n\u003cp\u003eFor\u0026nbsp;continuous variables that followed a normal distribution, data were expressed as\u0026nbsp;Mean \u0026plusmn; SD (Standard Deviation), and comparisons between groups were performed using\u0026nbsp;analysis of variance (ANOVA). However, for\u0026nbsp;continuous variables that did not conform to a normal distribution, results were presented as\u0026nbsp;Median (Interquartile Range, IQR), and\u0026nbsp;Kruskal-Wallis tests\u0026nbsp;were used for group comparisons.\u003c/p\u003e\n\u003cp\u003eFor categorical variables, data were reported as frequencies (%), and group comparisons were conducted using the chi-square (\u0026chi;\u0026sup2;) test or Fisher\u0026rsquo;s exact test, depending on the expected sample size distribution.\u003c/p\u003e\n\u003cp\u003eTo control for potential\u0026nbsp;confounding variables,\u0026nbsp;regression analyses\u0026nbsp;were performed to assess the impact of different\u0026nbsp;temporary fixation methods\u0026nbsp;on\u0026nbsp;clinical outcomes. For\u0026nbsp;continuous clinical outcomes, such as the\u0026nbsp;duration of definitive surgery,\u0026nbsp;linear regression\u0026nbsp;was applied. In contrast, for\u0026nbsp;binary clinical outcomes, including\u0026nbsp;infection rates, secondary surgery rates, and the proportion of patients achieving excellent-to-good outcomes on the Johner-Wruhs scoring system,\u0026nbsp;logistic regression\u0026nbsp;was used.\u003c/p\u003e\n\u003cp\u003eTo ensure the\u0026nbsp;validity and reliability of the regression models, diagnostic checks were conducted to verify that the assumptions of\u0026nbsp;linearity, normality of residuals, independence, and absence of multicollinearity\u0026nbsp;were met. The\u0026nbsp;multivariate model selection process\u0026nbsp;was based on three distinct strategies. The\u0026nbsp;first strategy\u0026nbsp;involved an\u0026nbsp;initial univariate screening, where variables with\u0026nbsp;P-values \u0026lt;0.1\u0026nbsp;were included in the multivariate model, followed by\u0026nbsp;stepwise regression. The\u0026nbsp;second strategy\u0026nbsp;entailed the inclusion of\u0026nbsp;all variables\u0026nbsp;into a\u0026nbsp;full model. The\u0026nbsp;third strategy\u0026nbsp;involved\u0026nbsp;stepwise selection\u0026nbsp;of variables from the\u0026nbsp;full model, utilizing an\u0026nbsp;Akaike Information Criterion (AIC)-based backward stepwise regression approach.\u003c/p\u003e\n\u003cp\u003eAmong the three models, the\u0026nbsp;model with the lowest AIC value\u0026nbsp;was selected as the\u0026nbsp;optimal model\u0026nbsp;for analysis. This model was subsequently used to estimate the\u0026nbsp;between-group differences\u0026nbsp;among the\u0026nbsp;three temporary fixation methods, including the\u0026nbsp;odds ratio (OR), 95% confidence interval (CI), and P-values.\u003c/p\u003e\n\u003cp\u003eAll statistical tests were conducted as two-sided tests, with a P-value of \u0026lt;0.05 considered statistically significant. This threshold ensured a rigorous evaluation of differences in clinical outcomes among the treatment groups, reinforcing the statistical credibility of the findings.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e1.5 Ethical Considerations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was approved by the Institutional Ethics Committee \u003cstrong\u003e(Approval Number: 20150513-018)\u003c/strong\u003e.\u003c/p\u003e\n"},{"header":"Results","content":"\u003cp\u003e\u003cstrong\u003e2.1 General Description of Early-stage treatment for Severe Lower Leg Injuries (Baseline Analysis)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe duration of temporary fixation surgery for the three treatment groups varied significantly. The external traction fixation group required an average of 15 \u0026plusmn; 5 minutes, while the calcaneal traction group had the shortest procedure time at 8 \u0026plusmn; 2 minutes. In contrast, the external skeletal fixation group had the longest procedure time, averaging 31 \u0026plusmn; 6 minutes.\u003c/p\u003e\n\u003cp\u003eIn terms of peak creatine kinase (CK) levels, which indicate the degree of muscle damage, the three groups showed distinct differences. The external traction fixation group recorded a median CK level of 520 (264, 957) U/L, while the calcaneal traction group had a lower median of 366 (164, 720) U/L. Conversely, the external skeletal fixation group exhibited the highest median CK levels at 883 (550, 1246) U/L, suggesting a greater degree of muscle injury in this group.\u003c/p\u003e\n\u003cp\u003eThe peak lactate levels, a marker of tissue perfusion and metabolic stress, also varied across groups. The external traction fixation group demonstrated the lowest mean lactate level at 2.09 \u0026plusmn; 0.60 mmol/L, while the calcaneal traction group exhibited a higher mean of 2.57 \u0026plusmn; 0.79 mmol/L. The external skeletal fixation group had an intermediate mean lactate level of 2.38 \u0026plusmn; 0.56 mmol/L.\u003c/p\u003e\n\u003cp\u003ePostoperative pain levels, assessed using the Visual Analog Scale (VAS) score, indicated notable differences among the groups. The external traction fixation group had a median VAS score of 2.00 (1.00, 3.00), while the calcaneal traction group reported a higher median pain score of 4.00 (3.00, 4.00), suggesting greater patient discomfort. The external skeletal fixation group had an intermediate median VAS score of 2.50 (2.00, 4.00).\u003c/p\u003e\n\u003cp\u003eThe time interval between temporary fixation and definitive surgery also varied among groups. The external traction fixation group had a mean interval of 8.1 \u0026plusmn; 2.6 days, while the calcaneal traction group had a slightly shorter interval of 7.6 \u0026plusmn; 2.5 days. In contrast, the external skeletal fixation group had the longest delay before definitive surgery, averaging 10.6 \u0026plusmn; 4.8 days.\u003c/p\u003e\n\u003cp\u003eA preliminary comparison between groups revealed statistically significant differences in temporary fixation surgery duration, interval to definitive surgery, VAS scores, and peak lactate levels. These findings suggest that different fixation methods have distinct impacts on operative efficiency, metabolic stress, pain levels, and recovery timelines. Further detailed statistical analyses of baseline characteristics are presented in Table 1.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.2 Evaluation of Efficiency and Safety\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo assess the efficiency of different early-stage fixation methods, definitive surgery duration was selected as the primary outcome variable. A linear regression analysis was conducted, incorporating temporary fixation methods as well as other potential confounding variables, including sex, age, laterality of injury, cause of injury, fracture location, AO fracture classification, pre-hospital delay, and presence of open fractures as independent variables. The results are presented in Table 2.\u003c/p\u003e\n\u003cp\u003eIn the univariate analysis, only the temporary fixation method showed statistical significance (P \u0026lt; 0.1). Variables identified as significant in the univariate analysis were further analyzed using stepwise regression, which resulted in a model (stepwise model 1) that included only the temporary fixation method. A full model was also constructed, incorporating all potential influencing factors identical to those in the univariate analysis. A stepwise selection process was then applied to the full model, yielding stepwise model 2, which included temporary fixation method and age as the final predictors. The results showed that the temporary fixation method was statistically significant (P \u0026lt; 0.001).\u003c/p\u003e\n\u003cp\u003eAcross different models, the findings consistently indicated that temporary fixation method had a significant impact on definitive surgery duration. To determine the most optimal model, we compared the Akaike Information Criterion (AIC) values for stepwise model 1, the full model, and stepwise model 2. The model with the smallest AIC value was selected as the optimal model, and this model was subsequently used for effect estimation.\u003c/p\u003e\n\u003cp\u003eTo evaluate infection rates following definitive surgery, a logistic regression analysis was conducted. The independent variables included temporary fixation method, sex, age, laterality of injury, cause of injury, fracture location, AO fracture classification, pre-hospital delay, presence of open fractures, VAS pain score, and pre-hospital delay. In the univariate analysis, temporary fixation method, AO fracture classification, and age were statistically significant (P \u0026lt; 0.1, see Table 3). After performing stepwise regression, the age variable was eliminated, resulting in stepwise model 1.\u003c/p\u003e\n\u003cp\u003eA full model was then built, incorporating all potential influencing factors. A stepwise selection process was applied to this model, producing stepwise model 2, which included temporary fixation method, cause of injury, AO fracture classification, and age. Through AIC comparison, stepwise model 2, which had the lowest AIC value, was selected as the optimal model. The odds ratio (OR) for temporary fixation method in this model indicated that the calcaneal traction group versus the external traction fixation group had an OR of 0.48 (95% CI: 0.02, 6.44), P = 0.6, while the external skeletal fixation group versus the external traction fixation group had an OR of 5.59 (95% CI: 0.85, 60.90), P = 0.1. Regarding AO fracture classification, the OR for type B fractures versus type A fractures was 0 (P \u0026gt; 0.9), while for type C fractures versus type A fractures, the OR was 0.69 (95% CI: 0.13, 3.65), P = 0.7.\u003c/p\u003e\n\u003cp\u003eTo assess unplanned secondary surgery rates, logistic regression analysis was again performed, using the same set of independent variables. In the univariate analysis, temporary fixation method was not significant (P \u0026gt; 0.1), but AO fracture classification and age showed statistical significance (P \u0026lt; 0.1, see Table 4). After stepwise regression, age was removed from the model, resulting in stepwise model 1. A full model was built using the same independent variables as the univariate analysis, and stepwise selection was applied, yielding stepwise model 2, which included temporary fixation method, AO fracture classification, and VAS pain score. Based on AIC comparisons, the model with the lowest AIC value was selected as the optimal model.\u003c/p\u003e\n\u003cp\u003eIn this model, the odds ratio (OR) for the calcaneal traction group versus the external traction fixation group was 7.27 (95% CI: 0.37, 300), P = 0.2, while the OR for the external skeletal fixation group versus the external traction fixation group was 11.8 (95% CI: 1.23, 310), P = 0.063. For AO fracture classification, the OR for type B fractures versus type A fractures was 0 (P \u0026gt; 0.9), while for type C fractures versus type A fractures, the OR was 0.15 (95% CI: 0.02, 1.00), P = 0.069.\u003c/p\u003e\n\u003cp\u003eFinally, the Johner-Wruhs score for excellent-to-good outcomes was analysed as an outcome variable using logistic regression. Independent variables included temporary fixation method, sex, age, laterality of injury, cause of injury, fracture location, AO fracture classification, pre-hospital delay, presence of open fractures, and VAS pain score. In the univariate analysis, both temporary fixation method and AO fracture classification were significant (P \u0026lt; 0.1, see Table 5). Stepwise regression was performed, resulting in stepwise model 1. A full model was then built with all relevant factors and subjected to stepwise selection, yielding stepwise model 2, which included only AO fracture classification.\u003c/p\u003e\n\u003cp\u003eAIC comparisons were performed, and the model with the lowest AIC value was selected as the optimal model. In this model, the OR for type B fractures versus type A fractures was 1.26 (95% CI: 0.22, 7.38), P = 0.8, while for type C fractures versus type A fractures, the OR was 0.27 (95% CI: 0.06, 1.01), P = 0.069.\u003cstrong\u003e\u003cbr\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.3 Definitive Surgical Outcomes for Severe Lower Leg Injuries in the Three Groups\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe results of the linear regression analysis for peak creatine kinase (CK) levels showed that the difference between the calcaneal traction group and the external traction fixation group was -115 (95% CI: -391.02, 161), p = 0.41. The difference between the external skeletal fixation group and the external traction fixation group was 278 (95% CI: 1.34, 554), p = 0.049.\u003c/p\u003e\n\u003cp\u003eThe results of the linear regression analysis for peak lactate levels indicated that the difference between the calcaneal traction group and the external traction fixation group was 0.517 (95% CI: 0.190, 0.844), p \u0026lt; 0.01, while the difference between the external skeletal fixation group and the external traction fixation group was 0.341 (95% CI: 0.007, 0.67), p = 0.046.\u003c/p\u003e\n\u003cp\u003eThe mean duration of definitive surgery for the three groups was 69 \u0026plusmn; 17 minutes, 89 \u0026plusmn; 15 minutes, and 88 \u0026plusmn; 15 minutes, respectively. Based on the selected optimal model, the marginal effect differences between the groups were compared. The difference in definitive surgery duration between the calcaneal traction group and the external traction fixation group was 20.60 minutes (95% CI: 12.76, 28.45), p \u0026lt; 0.001, while the difference between the external skeletal fixation group and the external traction fixation group was 19.59 minutes (95% CI: 11.62, 27.50), p \u0026lt; 0.001.\u003c/p\u003e\n\u003cp\u003eThe postoperative infection rates for the three groups were 6.7%, 3.1%, and 23%, respectively. The odds ratio (OR) for infection rates in the calcaneal traction group compared to the external traction fixation group was 0.48 (95% CI: 0.02, 6.44), p = 0.6, with a risk difference (RD) of -0.05 (95% CI: -0.26, 0.15), p = 0.61. The OR for infection rates in the external skeletal fixation group compared to the external traction fixation group was 5.59 (95% CI: 0.85, 60.90), p = 0.1, with an RD of 0.29 (95% CI: -0.02, 0.61), p = 0.07.\u003c/p\u003e\n\u003cp\u003eThe proportion of unplanned secondary surgeries in the three groups was 3.3%, 6.3%, and 17%, respectively. The OR for unplanned secondary surgeries in the calcaneal traction group compared to the external traction fixation group was 7.27 (95% CI: 0.37, 300), p = 0.2, with an RD of 0.05 (95% CI: -0.05, 0.15), p = 0.31. The OR for unplanned secondary surgeries in the external skeletal fixation group compared to the external traction fixation group was 11.8 (95% CI: 1.23, 310), p = 0.06, with an RD of 0.09 (95% CI: -0.04, 0.22), p = 0.18.\u003c/p\u003e\n\u003cp\u003eAt the final follow-up, the Johner-Wruhs excellent-to-good rating was 93%, 79%, and 73% for the three groups, respectively. The OR for achieving an excellent-to-good Johner-Wruhs score in the calcaneal traction group compared to the external traction fixation group was 0.26 (95% CI: 0.04, 1.17), p = 0.11, with an RD of -0.15 (95% CI: -0.32, 0.02), p = 0.08. The OR for achieving an excellent-to-good Johner-Wruhs score in the external skeletal fixation group compared to the external traction fixation group was 0.20 (95% CI: 0.03, 0.88), p = 0.05, with an RD of -0.20 (95% CI: -0.38, -0.02), p = 0.03. The results are presented in Table 6.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion:\u0026nbsp;\u003c/strong\u003eThe external traction fixation scaffold configuration is a practical technical choice for early limb stabilization in severe lower leg injuries.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003e\u003cstrong\u003e3.1 The results of this study indicate that\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eexternal traction fixation demonstrates a high level of safety in the early-stage treatment of severe limb injuries\u003c/strong\u003e\u003cstrong\u003e.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.1.1.\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eMuscle Tissue Safety Under Tension During External traction fixation Treatment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn the early-stage treatment of limb injuries, the prolonged\u0026nbsp;tensile mechanical environment\u0026nbsp;to which the injured limb is subjected raises concerns about\u0026nbsp;muscle tissue safety. Marson and Baldwin [20] suggested that\u0026nbsp;creatine kinase (CK) is an important indicator of skeletal muscle injury, while initial post-traumatic\u0026nbsp;lactate levels\u0026nbsp;are also associated with\u0026nbsp;skeletal muscle damage. Oladipo et al. [21] found that\u0026nbsp;elevated initial lactate levels in trauma patients undergoing lower limb long bone fracture fixation\u0026nbsp;were correlated with\u0026nbsp;postoperative complications, prolonged hospitalization, and increased hospital costs.\u003c/p\u003e\n\u003cp\u003eIn this study, the\u0026nbsp;early peak CK levels\u0026nbsp;in the\u0026nbsp;external traction fixation group\u0026nbsp;displayed significant\u0026nbsp;individual variation. Although the\u0026nbsp;estimated effect size of the intervention was large, the\u0026nbsp;confidence interval was wide, leading to\u0026nbsp;statistical insignificance. However,\u0026nbsp;lactate levels in the external traction fixation group were lower than those in both the calcaneal traction and external skeletal fixation groups. This could be attributed to the\u0026nbsp;pin insertion sites in external traction fixation being located away from the fracture zone, thereby\u0026nbsp;avoiding direct invasion of muscle tissue in the fracture area\u0026nbsp;and\u0026nbsp;preventing additional iatrogenic damage to the muscles within the compartment.\u003c/p\u003e\n\u003cp\u003eFurthermore, compared to\u0026nbsp;calcaneal traction and external skeletal fixation,\u0026nbsp;external traction fixation may reduce secondary soft tissue injury around the fracture under sustained traction tension. This suggests that\u0026nbsp;external traction fixation may offer better early protection for skeletal muscle and soft tissue compared to calcaneal traction.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.1.2.\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eHigh Safety of Pin Tract Management During Treatment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe early-stage treatment of severe lower leg injuries often requires external fixation, which has become a widely accepted approach [7, 22-24]. However, the technique of pin placement remains controversial. Bible et al.\u0026nbsp;[10]\u0026nbsp;recommended choosing\u0026nbsp;anatomical regions with minimal soft tissue coverage\u0026nbsp;for pin insertion. Additionally,\u0026nbsp;insertion into epiphyseal cancellous bone\u0026nbsp;is technically easier than\u0026nbsp;cortical bone placement.\u003c/p\u003e\n\u003cp\u003eStudies have shown that\u0026nbsp;thermal damage from drilling at the time of pin insertion\u0026nbsp;is associated with\u0026nbsp;pin loosening, with the\u0026nbsp;maximum temperature and duration of heating\u0026nbsp;being key influencing factors.\u0026nbsp;Pre-drilling before inserting the pin\u0026nbsp;has been shown to\u0026nbsp;significantly reduce thermal damage\u0026nbsp;[25].\u003c/p\u003e\n\u003cp\u003eIn the external traction fixation group, pins were inserted into the cancellous bone of the bone ends, resulting in lower thermal damage to the pin tract, thereby reducing the likelihood of pin loosening. Compared to external skeletal fixation, external traction fixation eliminates the need for\u0026nbsp;near fracture-line\u0026nbsp;site pin placement, reducing the overall incidence of pin tract infections. Furthermore, because pin insertion sites are positioned away from the definitive surgery area, even if pin tract infection occurs, it does not compromise the definitive surgery.\u003c/p\u003e\n\u003cp\u003eTherefore, the findings suggest that\u0026nbsp;traction-based pin insertion is a safe technique\u0026nbsp;that can effectively\u0026nbsp;reduce the incidence of pin tract infections after definitive surgery. This study supports the conclusion that\u0026nbsp;external traction fixation is a safe temporary fixation method when applied within an appropriate range of tissue tension.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.2 This study also demonstrated that\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eexternal traction fixation is an efficient method for temporary limb stabilization\u003c/strong\u003e\u003cstrong\u003e.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.2.1.\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eHigh Reduction Efficiency\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis type of external fixation can function as a fracture reduction device during the early fixation period. Zhang Yingze et al. previously applied the \u0026ldquo;bidirectional device\u0026rdquo;\u0026nbsp;for rapid assisted reduction in lower limb long bone fractures, achieving minimally invasive surgical outcomes.\u003c/p\u003e\n\u003cp\u003eDuring the traction phase and definitive surgery, bidirectional device\u0026nbsp;traction can be used to maintain fracture reduction, assisting in the completion of intramedullary nailing or minimally invasive plate fixation. External traction fixation not only temporarily stabilizes the injured limb during staged treatment of severe lower leg injuries but also provides muscle tension control, mechanical axis stability, pain relief, and ease of mobilization. Additionally, the circular support provided by the device to the fracture site minimizes soft tissue swelling and reduces the risk of compartment syndrome.\u003c/p\u003e\n\u003cp\u003eThroughout the treatment period,\u0026nbsp;patients in the external traction fixation group reported significantly lower pain scores compared to the other two groups, indicating a\u0026nbsp;higher level of subjective comfort. During\u0026nbsp;definitive surgery, external traction fixation-maintained\u0026nbsp;fracture reduction, thereby facilitating the completion of\u0026nbsp;intramedullary nailing or minimally invasive plate osteosynthesis (MIPO). Due to\u0026nbsp;adequate and effective fracture reduction, the\u0026nbsp;reduction step was no longer required during definitive surgery in this group, resulting in\u0026nbsp;a significantly shorter surgery duration compared to the other two groups.\u003c/p\u003e\n\u003cp\u003eIn contrast, the\u0026nbsp;calcaneal traction group faced limitations due to inconsistent and insufficient traction forces, leading to\u0026nbsp;soft tissue contractures, which increased the\u0026nbsp;difficulty of fracture reduction during definitive internal fixation surgery, ultimately\u0026nbsp;prolonging surgical duration.\u0026nbsp;Linear regression analysis confirmed that the temporary fixation method significantly influenced definitive surgery duration.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.2.2.\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eHigh Efficiency in Protecting the Periosteum and Soft Tissues\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAccording to the AO\u0026nbsp;Organization [11], external fixation devices used for damage control orthopaedic (DCO) surgery should be placed outside the injury zone and, ideally, should not interfere with the area designated for definitive surgery. The high-spanning configuration of external traction fixation fully aligns with AO principles, providing ample space for surgical incision selection and demonstrating high compatibility with definitive surgery.\u003c/p\u003e\n\u003cp\u003eThis study also confirmed that\u0026nbsp;external traction fixation can be retained during definitive surgery, assisting in\u0026nbsp;fracture reduction for minimally invasive plate osteosynthesis (MIPO) or tibial intramedullary nailing techniques. This approach significantly\u0026nbsp;reduces the duration of definitive internal fixation surgery, and the\u0026nbsp;reserved soft tissue pathway does not interfere with implant placement.\u003c/p\u003e\n\u003cp\u003eThe significantly\u0026nbsp;shorter definitive surgery time in the external traction fixation group\u0026nbsp;compared to the control groups suggests that this\u0026nbsp;temporary fixation method is highly compatible with definitive surgery. Compared to\u0026nbsp;calcaneal traction and external skeletal fixation,\u0026nbsp;external traction fixation demonstrates superior periosteal and soft tissue protection\u0026nbsp;and greater compatibility with\u0026nbsp;definitive surgical procedures, ultimately\u0026nbsp;contributing to faster fracture healing.\u003c/p\u003e\n\u003cp\u003eBased on\u0026nbsp;final treatment outcomes and patient comfort during the treatment process,\u0026nbsp;external traction fixation proves to be a practical and effective temporary fixation method.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.3 Observational Period for Early Treatment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn this study, the\u0026nbsp;early-stage treatment observation period was generally controlled within 7 days, based on the following considerations:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e1.\u0026nbsp;Severe complications such as compartment syndrome typically develop within 48 to 72 hours. After\u0026nbsp;5 to 7 days of observation, a\u0026nbsp;clear diagnosis\u0026nbsp;can usually be established, allowing for the formulation of a\u0026nbsp;definitive surgical plan.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e2.\u0026nbsp;Patients with shock, traumatic brain injury, or chest trauma\u0026nbsp;often require\u0026nbsp;7 to 10 days for systemic stabilization, necessitating an adequate observation period.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e3.\u0026nbsp;Elderly trauma patients\u0026nbsp;often require additional time for\u0026nbsp;preoperative assessment and management of underlying medical conditions, necessitating thorough\u0026nbsp;preoperative preparation.\u003c/p\u003e\n\u003cp\u003eThe\u0026nbsp;damage control orthopaedic (DCO) concept\u0026nbsp;has been widely adopted worldwide, demonstrating\u0026nbsp;positive clinical outcomes. It is generally accepted that\u0026nbsp;when patients are at risk of the \u0026ldquo;lethal triad,\u0026rdquo; performing early definitive internal fixation is too risky, necessitating a\u0026nbsp;staged surgical approach, where\u0026nbsp;external fixation is applied first, followed by definitive internal fixation\u0026nbsp;[3-5].\u003c/p\u003e\n\u003cp\u003eOladipo et al. [21], in a large-scale retrospective clinical study, suggested that even in cases without life-threatening conditions, adopting a proactive staged treatment strategy for severe limb injuries\u0026mdash;particularly in elderly patients, those with unclear medical histories, limited hospital blood reserves, or inadequate surgical expertise\u0026mdash;can lead to better clinical outcomes [21, 26].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.4 Study Limitations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study has several limitations, including\u0026nbsp;a small sample size\u0026nbsp;and\u0026nbsp;a single-centre design. Several outcome measures, such as\u0026nbsp;peak CK, infection rates after definitive surgery, unplanned secondary surgery rates, and Johner-Wruhs excellent-to-good outcomes, did not reach statistical significance, likely due to\u0026nbsp;insufficient sample size. Future studies will aim to\u0026nbsp;expand the sample size and further validate these findings.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eConflict of Interest Statement:\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll JTACS Disclosure forms have been supplied and are provided as supplemental digital content.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical Review Statement:\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis study was approved by the Medical Ethics Committee of the Air Force Hospital of Eastern Theatre Command \u003cstrong\u003e(Approval Number: 20150513-018)\u003c/strong\u003e.\u003c/p\u003e\n\u003cp\u003eThis study was conducted in accordance with the Declaration of Helsinki. As this was a retrospective analysis of anonymized clinical data, individual informed consent was waived by the Ethics Committee of the Air Force Hospital of Eastern Theatre Command.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contribution Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eLi Ying was responsible for the conceptualization, methodology, and supervision of the study.\u003c/p\u003e\n\u003cp\u003eYang Junsheng contributed to the methodology, data curation, investigation, original draft writing, and supervision.\u003c/p\u003e\n\u003cp\u003eYang Zhiwei contributed to the methodology, data curation, formal analysis, and original draft writing.\u003c/p\u003e\n\u003cp\u003eZhao Lei contributed to formal analysis and resource provision.\u003c/p\u003e\n\u003cp\u003eWang Zixu participated in the investigation.\u003c/p\u003e\n\u003cp\u003eXue Qing participated in the investigation.\u003c/p\u003e\n\u003cp\u003eSun Zhongyang participated in the investigation and original draft writing.\u003c/p\u003e\n\u003cp\u003eTong Liangsheng contributed to resource provision and methodology.\u003c/p\u003e\n\u003cp\u003eLiu Jin contributed to formal analysis and manuscript review and editing.\u003c/p\u003e\n\u003cp\u003eAll authors have read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability Declaration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and/or analysed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo external funding was received for this study.\u003cbr\u003e\u0026nbsp;\u003c/p\u003e"},{"header":"Reference","content":"\u003col\u003e\n \u003cli\u003eHiggin RP, Palmer J, Qureshi AA, Hancock NJ. Patient reported outcomes after definitive open tibial fracture management. Injury. 2022;53:3838-42.\u003c/li\u003e\n \u003cli\u003eMundi R, Chaudhry H, Niroopan G, Petrisor B, Bhandari M. Open Tibial Fractures: Updated Guidelines for Management. JBJS Rev. 2015;3.\u003c/li\u003e\n \u003cli\u003eTesso CB, Mohammed T, Teshome B, Ayalew K, Kebede S. Magnitude of infection and associated factors in open tibial fracture treated operatively, in Addis Ababa burn emergency and trauma center. Eur J Orthop Surg Traumatol. 2024;35:46.\u003c/li\u003e\n \u003cli\u003eBlachut PA, Meek RN, O\u0026apos;Brien PJ. External fixation and delayed intramedullary nailing of open fractures of the tibial shaft. A sequential protocol. J Bone Joint Surg Am. 1990;72:729-35.\u003c/li\u003e\n \u003cli\u003eHorst K, Andruszkow H, Weber C, Dienstknecht T, Hildebrand F, Tarkin I, et al. Standards of external fixation in prolonged applications to allow safe conversion to definitive extremity surgery: the Aachen algorithm for acute ex fix conversion. Injury. 2015;46 Suppl 3:S13-8.\u003c/li\u003e\n \u003cli\u003eKucukdurmaz F, Alijanipour P. Current Concepts in Orthopedic Management of Multiple Trauma. Open Orthop J. 2015;9:275-82.\u003c/li\u003e\n \u003cli\u003eGuerado E, Bertrand ML, Cano JR, Cervan AM, Galan A. Damage control orthopaedics: State of the art. World J Orthop. 2019;10:1-13.\u003c/li\u003e\n \u003cli\u003eZiran BH, Smith WR, Anglen JO, Tornetta P, 3rd. External fixation: how to make it work. J Bone Joint Surg Am. 2007;89:1620-32.\u003c/li\u003e\n \u003cli\u003eEriksson A, Albrektsson T, Grane B, McQueen D. Thermal injury to bone. A vital-microscopic description of heat effects. Int J Oral Surg. 1982;11:115-21.\u003c/li\u003e\n \u003cli\u003eBible JE, Mir HR. External Fixation: Principles and Applications. J Am Acad Orthop Surg. 2015;23:683-90.\u003c/li\u003e\n \u003cli\u003eMukhopadhaya J, Jain AK. AO Principles of Fracture Management. Indian Journal of Orthopaedics. 2019;53:217-8.\u003c/li\u003e\n \u003cli\u003eMichael DS, Ali A, Joseph KA, John C, Geoffrey SM. Safety of Skeletal Traction through the Distal Femur, Proximal Tibia, and Calcaneus. Archives of Trauma Research. 2019;8:198-202.\u003c/li\u003e\n \u003cli\u003eTri Sastra Pradhini DP. Skeletal Traction: an Overview of Techniques, Indications, and Considerations. Lombok Medical Journal. 2024.\u003c/li\u003e\n \u003cli\u003eDatumanong-Mala. ND. NURSING MANAGEMENT OF COMPLICATIONS IN PATIENTS WITH SKELETAL TRACTION. Int J of Adv Res. 2019.\u003c/li\u003e\n \u003cli\u003eSchade AT, Sabawo M, Nyamulani N, Mpanga CC, Ngoie LB, Metcalfe AJ, et al. Functional outcomes and quality of life at 1-year follow-up after an open tibia fracture in Malawi: a multicentre, prospective cohort study. Lancet Glob Health. 2023;11:e1609-e18.\u003c/li\u003e\n \u003cli\u003eChen W, Zhang T, Wang J, Liu B, Hou Z, Zhang Y. Minimally invasive treatment of displaced femoral shaft fractures with a rapid reductor and intramedullary nail fixation. Int Orthop. 2016;40:167-72.\u003c/li\u003e\n \u003cli\u003eGuo J, Yin Y, Jin L, Zhang R, Hou Z, Zhang Y. Acute compartment syndrome: Cause, diagnosis, and new viewpoint. Medicine (Baltimore). 2019;98:e16260.\u003c/li\u003e\n \u003cli\u003eOsborn CPM, Schmidt AH. Management of Acute Compartment Syndrome. J Am Acad Orthop Surg. 2020;28:e108-e14.\u003c/li\u003e\n \u003cli\u003eJohner R, Wruhs O. Classification of tibial shaft fractures and correlation with results after rigid internal fixation. Clin Orthop Relat Res. 1983:7-25.\u003c/li\u003e\n \u003cli\u003eMarson JW, Baldwin HE. The creatine kinase conundrum: a reappraisal of the association of isotretinoin, creatine kinase, and rhabdomyolysis. Int J Dermatol. 2020;59:279-83.\u003c/li\u003e\n \u003cli\u003eOladipo V, Portney D, Haber J, Baker H, Strelzow J. Lactic acid levels are associated with morbidity, length of stay, and total treatment costs in urban trauma patients with lower extremity long bone fractures. Eur J Orthop Surg Traumatol. 2024;34:1963-70.\u003c/li\u003e\n \u003cli\u003eYakkanti M, Mauffrey C, Roberts CS. Limb Damage Control Orthopedics. Springer London; 2012. p. 29-41.\u003c/li\u003e\n \u003cli\u003eDe Coster T. Timing and Strategies for Definitive Fixation After a Damage Control Frame. Springer London; 2012. p. 185-209.\u003c/li\u003e\n \u003cli\u003eMatsumura T, Takahashi T, Miyamoto O, Saito T, Kimura A, Takeshita K. Clinical outcome of conversion from external fixation to definitive internal fixation for open fracture of the lower limb. J Orthop Sci. 2019;24:888-93.\u003c/li\u003e\n \u003cli\u003eMatthews LS, Green CA, Goldstein SA. The thermal effects of skeletal fixation-pin insertion in bone. J Bone Joint Surg Am. 1984;66:1077-83.\u003c/li\u003e\n \u003cli\u003eHaller JM, Holt D, Rothberg DL, Kubiak EN, Higgins TF. Does Early versus Delayed Spanning External Fixation Impact Complication Rates for High-energy Tibial Plateau and Plafond Fractures? Clin Orthop Relat Res. 2016;474:1436-44.\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 to 6 are available in the Supplementary Files section\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Early-stage treatment, External traction fixation, Calcaneal traction, External skeletal fixation, Retrospective cohort study, Severe limb injuries","lastPublishedDoi":"10.21203/rs.3.rs-6934471/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6934471/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eBackground: Staged treatment is commonly used for severe limb injuries, and optimizing early stabilization is crucial for successful definitive surgery. Calcaneal traction and external skeletal fixation are widely applied; however, both have limitations— discomfort of bedrest and traction line swing, or infection risk and surgical planning difficulty. Meanwhile, external traction fixation, a hybrid technique structurally similar to external fixation but biomechanically akin to skeletal traction, offers both mechanical stability and procedural convenience. This study aims to evaluate the safety and efficacy of external traction fixation as an early-stage treatment for severe lower leg injuries.\u003c/p\u003e\n\u003cp\u003eMethods: We retrospectively analysed data from 92 patients with severe lower leg injuries treated at our hospital between May 2016 and May 2022. Patients (72 males, 20 females; mean age 46.6 ± 13.3 years) were divided into three groups based on the initial temporary fixation method: external traction fixation (Group A), calcaneal traction (Group B), and external skeletal fixation (Group C). Outcomes included peak creatine kinase and lactate levels within 48 hours post-injury, peak Visual Analog Scale (VAS) scores within 24 hours post-fixation, duration of the temporary fixation procedure, time to definitive surgery, and duration of definitive internal fixation. Limb function was evaluated at final follow-up using the Johner-Wruhs criteria.\u003c/p\u003e\n\u003cp\u003eResults: Peak lactate levels were significantly lower in the external traction fixation group (Group A) compared to the other groups. The mean duration of definitive surgery was 69 ± 17 minutes (Group A), 89 ± 15 minutes (Group B), and 88 ± 15 minutes (Group C). After adjusting for confounders, definitive surgery was significantly shorter in Group A compared to Group B (mean difference: 20.60 minutes; 95% CI: 12.76–28.45; p \u0026lt; 0.001) and Group C (mean difference: 19.59 minutes; 95% CI: 11.62–27.50; p \u0026lt; 0.001). Postoperative infection rates were 7% (Group A), 3% (Group B), and 23% (Group C), with no significant difference after adjustment. The final excellent-good outcome rates (Johner-Wruhs criteria) were 93% (Group A), 78% (Group B), and 73% (Group C), with a significant difference between Group A and Group C.\u003c/p\u003e\n\u003cp\u003eConclusion: In the early-stage treatment of severe lower leg injuries, using external traction fixation to stabilize the injured limb is a safe and efficient technical choice. It is well compatible with subsequent definitive surgery and better facilitates the staged treatment strategy for severe limb injuries.\u003c/p\u003e","manuscriptTitle":"Preliminary exploration of safety and efficiency of external traction fixation in early-stage treatment of severe lower leg injuries--A retrospective cohort study","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-07-03 08:26:22","doi":"10.21203/rs.3.rs-6934471/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"bc6aaa49-9f9f-4a4e-875d-d845315b86f4","owner":[],"postedDate":"July 3rd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-10-16T16:08:11+00:00","versionOfRecord":[],"versionCreatedAt":"2025-07-03 08:26:22","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6934471","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6934471","identity":"rs-6934471","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}